Nova Biomedical Corporation Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA
Brand
Nova Biomedical Corporation
Lot Codes / Batch Numbers
Lot Numbers: 610633, 701034, 704053, 707222
Products Sold
Lot Numbers: 610633, 701034, 704053, 707222
Nova Biomedical Corporation is recalling Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA due to Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples
Recommended Action
Per FDA guidance
Nova issued a Customer Advisory Notice notification by phone on 9/17/07 to contact customers using a script . If the facility reports Normalized Ionized Calcium or Normalized Ionized Magnesium, Nova Biomedical will replace existing stock of Nova 8 calibrator packs. If the facility does not report Normalized Ionized Calcium or Normalized Ionized Magnesium, the account can continue to use the existing lot of calibrator packs.This contact will be documented within the Nova Biomedical complaint database. Intemational Customer Advisory Notice being sent to Nova Biomedical Subsidiariies and Distributors by Federal Express Envelope.The Federal Express envelopes tracking number will be used for delivery confirmation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026